PMA supplement
N17511 S011: HYSKON (32% DEXTRAN 70)
FDA PMA supplement · Normal 180 Day Track · Coopervision Surgical
Key facts
| Original PMA | N17511 |
|---|---|
| Supplement number | S011 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | HYSKON (32% DEXTRAN 70) |
| Generic name | FLUID, HYSTEROSCOPY |
| Applicant | Coopervision Surgical |
| Product code | LTA |
| Received date | Nov 10, 1994 |
| Decision date | Jul 18, 1995 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: